tlc9803_EN2008.08.27

TLC9803 Dynamic ECG Systems User Manual

Foreword

This user manual describes features and request of this product, main structure, function, specification,

correct method for transportation, installation, usage, operation, repair, maintenance and storage, as well

as the safety procedure to protect both the user and equipment. Refer to the respective chapters for

details.

Please read this user manual before using the product, and operate according to this manual strictly. As

for abnormality, human injury and equipment damages caused by wrong operation, which violates the

rules in manual, our company without responsibility for this kind of danger and will not maintain free

for this kind of malfunction.

The information contained in this document is subject to change without notice.

I

TLC9803 Dynamic ECG Systems User Manual

CONTENTS

Chapter 1 Introduction...............................................................................................................................1

1.1 Environment Condition....................................................................................................................1

1.2 Product Feature................................................................................................................................1

1.3 Safety...............................................................................................................................................1

1.4 Maintenance and Cleaning...............................................................................................................2

Chapter 2 Frame character of product.......................................................................................................3

2.1 Sketch map for every orientation.....................................................................................................3

2.2 Defination of keystoke,interface and indicator light........................................................................4

Chapter 3 Preparing work before using.....................................................................................................5

3.1 Electrodeplacement..........................................................................................................................5

3.2 Battery installation and notice..........................................................................................................6

Chapter 4 Recorder Operation explanation................................................................................................8

4.1 New record.......................................................................................................................................8

4.2 Review record................................................................................................................................10

4.3 System set......................................................................................................................................11

4.4 Replay record.................................................................................................................................13

Chapter 5 Malfunction analysis and Troubleshooting.............................................................................15

5.1 The problem related to the battery.................................................................................................15

5.2 Thep roblem related to the skin and the electrode.........................................................................16

5.3 The problem related to the cable and the inputplug.......................................................................16

5.4 Other problems..............................................................................................................................17

Chapter 6 Instructions for Analysis Software .........................................................................................18

Appendix Ⅰ TechnicalSpecification..........................................................................................................52

II

TLC9803Dynamic ECG Systems User Manual

Chapter 1 Introduction

1.1 Environment Condition

The environment requirement of operation ,transport and storage for Dynamic ECG System：

Operation Environment:

Environment Temperature: 10℃～45℃

Relative Humidity: ≤85%

Atmospheric pressure : 86 kPa～106 kPa

Power Supply: DC 3V

Transport and Storage Environment：

Environment Temperature: -40℃～+55℃

Relative Humidity: ≤85%

Atmospheric pressure: 86 kPa～106kPa

1.2 Product Feature

TLC9803 Dynamic ECG Systems contain recorder & analysis software.Recorder is an easy- to -use unit,

which collects 3-lead ECG waveform synchronously and records continuously for 24 hours.In addition ,

it also reviews ECG waveform.It is easy for you to use analysis software which plays back ECG

waveform stored in ambulatory recorder and achieves kinds of analysis functions ,such as

arrhythmia ,HRVA,etc.

1.3 Safety

The design of TLC9803 Dynamic ECG Systems accords with the international safety standard

IEC60601-2-47.

Warning :

Please don't use this device with the defibrilation device.

Please don’t operate this device in environment containing flammable anaesthesia gas.

Please don't use this device when scanning MRI.

Please don't use device which has High level electromagnetic radiation in the vicinity of the

recorder.

The device is not intended for synchronous gathering.

Note :

TLC9803 Dynamic ECG Systems must be operated by the personnel who has been trained and

1


authorized.Person specially assigned for safe keeping.

Please read this user manual carefully before using the product, and operate

according to this manual strictly

The environment where the device will be used should be reasonably free from vibration, dust,

corrosive or combustible matter, and shun extremes of temperature and humidity, and so on.

Doctor must tell patient monitored by recorder not to do much movement.

Please insert the batteries properly in the right direction for the improper insertion may damage

the device.

For protecting environment, please deal with the batteries according to the local rule of law.

1.4 Maintenance and Cleaning

The recorder can be cleaned with hospital-grade ethanol and dried in air or with dry and clean cloth.

Please take out the batteries if the recorder is not in use for a long time and proper safekeeping.

2


Chapter 2 Frame character of product

2.1 Sketch map for every orientation

2.1.1 Front view

3


4


Fig 2-1 Front view

2.1.2 Planform

5


6


Fig. 2-2 Planform

Note:While connecting lead wires , please refer to lead wires indicator in figure 2-4

2.1.3 Side view

Fig.2-3 Side view

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2.1.4 Bottom view

8


9


Fig.2-4 Bottom view

2.2 Definition of keystoke,interface and indicator light

function key: marker/affirmance/choice

function key: menu/cancel/turn on/off

direction key: left

direction key: right

direction key: go up

direction key: go down

indicator light:（glint every 4 seconds when collecting ECG signal） Show date transfers state when connecting with the computer.

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Chapter 3 Preparing work before using

3.1 Electrode placement

Note :

The placement of electrode is the basic of holter recorder collecting ECG data signal. The quality

and position of electrode affect the quality of ECG signal. Please read this chapter carefully before

first operation.

Position of the electrode placement is shown as fig.3-1

fig. 3-1

Deal with the skin

When attaching and placing the electrode, we need to deal with the skin at first, and be sure to clean the

skin. Use 95% alcohol to scrub the skin, after the alcohol evaporates, use abrasive paper attached to the

electrode to wipe the attached place to remove cuticula on the surface of the skin in order to reduce the

resistance from the skin and the disturbance from the EMG。People who have much hair need to shave it

to ensure the skin well connected with the electrode. The skin of old patients is dry and has many

crinkles, so we have to clean the skin and make the attached place flat. If the attached place is near the

bosom of the woman patient, electrode and cables should be covered by the bra and then fixed well.

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Place the electrode

Use high-quality ECG electrode to attach the right place and connect with the correspond electrode. To

prevent the electrode drop and the baseline excursion coursed by pulling，use the medical adhesive belt

or plaster to fix every electrode and cable properly. After the cables get together, use the adhesive belt to

fix in the abdomen; the rest cables can be tucked into the recorder’s waistband. Don’t use the common

adhesive belt to attach the cables for fear of dirtying, corroding the cables and reducing the usage life

span. If use the device in the environment of high temperature or easy perspiring, “EKG Medical Gel”

could be wiped on the skin around the electrode beforehand。

3.2 Battery installation and notice

3.2.1 Open the battery cover according to the direction which the arrowhead on the cover

indicates.Follow as fig.3-2.

Fig. 3-2

3.2.2 Please insert the batteries properly in the right direction, and then close the cover. Follow as

fig.3-3。

Fig. 3-3

3.2.3 The state of battery and working requirements are shown as table 3-a1。

The batteries are full, the device could run in gear .

The batteries are insufficient,suggest not record.

The batteries are almost drained,please replace the battery immediately.

Table 3-a1

When the batteries are almost drained and not replaced,the recorder will show the interface as 12


fig.3-4,and turn into protected mode .

Fig. 3-4When the energy of battery is low,the recorder turn into protected mode in order to protect the recorder

from damaging .Under protected mode the device don't run until the device is electricized by USB or the

batteries are full.

Warning：

The batteries should be full when the device collects new information,otherwise the recording time

could not last long enough.

Note：

Please confirm all eletrodes and lead wires are connected well to patient.Otherwise ,interference in

waveform at the beginning of record may lead to failure analysis.

Note：

Please take off the battery after monitoring in order to protect the recorder from damaging

because of battery leak.

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Chapter 4 Recorder Operation explanation

Press for about 3 seconds to turn on the recorder (press

for about 3 seconds to turn off the recorder on the main interface ) , the main interface is shown in fig.4-1。

fig. 4-1 main interface

Choice state

state time Battery State

Option area

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4.1 New record

Use or to choose on main interface,press

to enter new record operation,display interface is as fig.4-2.

fig. 4-2

On the interface , press or to change the gain, press

or to switch lead status.

After recording one time, press if you want to continue to record ,here the

interface will show the information "Last record will be covered !Are you sure ?" as fig.4-3.

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fig. 4-3

Press to cancel recording and return to the main interface .

Press to continue to record and the interface will show the information "Starting record" as fig.4-4.

fig. 4-4

The interface as fig.4-4 will last 2 seconds ,then the recorder enter stand-by mode.The blue indicator on

the top left corner of recorder will glitter one time every 4 seconds to show the state in gear.

Press for about 3 seconds to record event marker when recording,in the

meanwhile,the beep from recorder indicates you have succeeded in event marker.

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Press for about 3 seconds when recording if you want to end recording

manually,then the recorder will show the information as fig.4-5 to affirm whether the recording

operation will be stopped.

fig. 4-5

If you confirm that you want to terminate recording,please press for about 3 seconds

according to the information shown on the interface,at the same time the screen will display the

information as fig.4-6.This interface will last about 2 seconds ,then return to the main interface.

fig. 4-6

4.2 Review record

Use or to choose on main interface，press

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to enter review record operation interface ,if the recorder has storage

record,there will be a interface as fig.4-7：

fig. 4-7

Under this interface,use or to change lead marker（Ⅰ、Ⅱ、Ⅲ、

AVR、AVL、AVF、V1、V2、V3、V4、V5、V6），press to switch between

hour,minute and second,the red one shows the option which has been chosen,use or

to change the value.

If the recorder doesn't have storage record,there will be a "No record" information on the screen as fig.4-

8,and the interface will return main interface automatically after 2 seconds.

Lead state marker

waveform display starting time

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fig. 4-8

4.3 System set

Use or to choose on main interface，press

to enter the "system set" interface as fig.4-9

fig. 4-9

Use or to choose the option ， use or

to set the option which has been chosen or enter the inferior menu, the red one shows

the option which has been chosen.

① Auto shutdown set

①②

③④

⑤

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The time scope of auto shutdown is 3~98 seconds，if setting 99s，the recorder will be on forever.

② keypad tone set

Under this option,you can decide the keypad tone "ON/OFF".

③ Demo mode

Under the item , the demonstration waveform is shown in figure 4-10

Fig. 4-10

Press to switch ECG lead waveform..User can choose 3-lead ECG waveform or single

ECG waveform displayed on the OLED screen.

④ system initialization

Press to enter the interface as shown in figure 4-11.

Fig. 4-11Note：

Detailed edition information depends on current recorder.

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Press to enter the initialization interface as shown in figure 4-12

Fig. 4-12⑤ Time set

Press to enter the time set interface as fig.4-13.

fig. 4-13

Use or to choose the option ,use or

to change the value,press to save the setting and return

21


superior menu .Press to cancel setting and return superior menu.

4.4 Replay record

Please remove electrodes from patient ,and then connect recorder to PC with USB cable.It is

recommended that batteries should be remained in the recorder .The indicator light is on ,and the

interface displays the information as shown in fig.4-14 if the connection is normal.

fig. 4-14In "My computer" of PC ,there is a symbol as fig.4-15

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fig. 4-15

Open the disk ,you can see a file named ECG_WAVE.BIN ,as fig.4-16

fig. 4-16

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Please choose this file of analyse software to perform the replaying operation.

Note：

Please refer to the information of chapter 6 for the detail.

After replaying ,please safley remove USB Mass Storage Device as fig.4-17， then pull out USB

connecting line to avoid damaging the device .

fig. 4-17

After cutting the connection with PC,this device will go back to the main interface.

Note：

The USB interface of recorder is USB2.0,please choose the USB2.0 interface in PC to connect in

order to make sure the speed of data communication.

Chapter 5 Malfunction analysis and Troubleshooting 5.1 The problem related to the battery

Problem Cause Correction

The recorder has no response and the indicator isn’t light after the battery is put in.

1.The battery is used up. Change another battery.

2.The battery can’t connect with the reed very well. The height of “+” of some brand of battery is too low.

Change another brand of battery. or put a thick of metal piece in the place between the “+” of battery and reed.

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3.The direction of the battery is wrong.

Install the battery correctly once again.

The record time of the recorder can’t reach 24 hours.

1.The quality of the battery is poor. or the battery has been put for a long time.

Change another high-quality new battery.

2.The battery can’t be charged enough.

Recommend to use the battery whose capacity is over 1000mAh.

3. The characteristic and brand of the battery are different.

Change another new battery.

The data can’t be cleared away.

1. If the voltage above 3.5V, which beyond the working voltage, part of the electron hard disk may be broken.

Please contact our company.

2. Some part of the recorder may be damaged because the electrolyte in the battery flows out.

Please contact our company.

5.2 The problem related to the skin and the electrode.


The wave is disturbed; the quality of the ECG signal is poor.

1. The skin can’t be cleaned well, or the electrode isn’t attached right.

Clean the skin and attach once more.

2. The quality of the one-off electrode is poor, or the electrode has been stored for a long time.

Use new, high-quality electrode.

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3. The movement of the patient’s upper limbs is too server

Ask the patient to avoid server movement when monitoring.

The amplitude of some ECG wave is small, which is difficult for analysis.

The cable is broken. Change a new cable.

5.3 The problem related to the cable and the input plug


The output wave of the recorder is a straight line.

1. The recorder isn’t connected well.

Please check if the needles of the plug is curved, broken or lack. If the plug is well, please connect once again.

2. The cable is broken. Please contact our cmpany.

3. The recorder is broken. Please contact our cmpany.

Some ECG wave is disturbed a lot, and the quality of ECG signal is poor.

1. The cable isn’t connected wellConnect the cable once again according to the operation manual.

2. Lead cable is broken. Please change a new one.

3. The quality of the one-off electrode is poor.

Please change new, high-quality electrode.

5.4 Other problems


The communication of data is failed.

There is something wrong with the USB cable.

Change another USB cable.

The USB interface of computer don't match the USB interface of the recorder.

Use 2.0 interface。

26


Chapter 6 Instructions for Analysis Software

Turn on the computer and enter the WINDOWS98/2000/XP operation system. Double click the

TLC9803 graph on the desktop, then enter the TLC9803 Dynamic ECG operation systems As fig.6-1.

27


fig. 6-1

Replay HOLTER recorder

Click the “New” in the menu of “File” or click , and input the new patient information.

If the recorder use SD memory,please choose the collection file ECG_WAVE.BIN as fig.6-2

first.Certainly you could also copy the case history to other place,then choose.If the recorder use Flash

memory，please turn to fig.6-2.

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fig. 6-2

The doctor input the new information about the patient.

Attention!! If the patient takes a pacemaker, choose “Y” in the item “pacing”, then the system can add

the function of pacing analysis.

Connect the HOLTER recorder with the computer, and then click the , the computer begins

to read data from the recorder. After the communication finished, enter the interface as fig.6-3.

Note: Replay the same recorder, you must unplug the replaying cable and connect again, then begin to

operate.

This menu is to ask whether to make the arrhythmia analysis.Click button as fig.6-3 , and

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enter the analytical interface as fig.6-5.

fig. 6-3

Attention!! If the patient takes a pacemaker,first enter the dialog box as fig.6-4, the doctor modify the

items on the dialog box according to the parameter of pacemaker. The accuracy of pacing pulse analysis

relatives to the “high” or “low” of pacing pulse, usually choose "middle", if the pulse is very low ,please

choose the " high".

fig. 6-4

Click button, and enter the module compilation (have analysed) or order replaying

interface (have not analysed).Click to enter the interface as shown in fig.6-5

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fig. 6-5

The interface as fig.6-5 is to ask the user to choose a meaningful wave to diagnose and adjust the value

of ST segment. Look at the picture. The three colored lines from left to right are baseline point,ST

segment beginning point, and ST segment ending point. When clicking, the line, which is near the

clicking point, will be changed.

The right side of the picture is the control view,the "manual intervention" option is designed for

extending function.

If the current wave is good, please knock the button, and then the system enters the

arrhythmia analysis as fig.6-6. If the user wants to stop arrhythmia analysis, please close direct .31


If the current wave is not good, please click the button, then the system will show the waves

constantly until you click to enter the arrhythmia analysis .

Click the dialog box at the right of the main analytical lead to choose main analytical lead.

RR refractory period: This parameter is general 300ms, it means the shortest time between the two heart

beats, the default value is 300ms, the user can adjust it according to the concrete circumstance, if the

patient’s heart rate is very quick, it should be set lower, in order to prevent losing the analysis for some

heart beats.

Click the options under the “analysis leads” to decide which leads to be analysed,the default is 8-lead

When the amplitude of the case’s wave is too low, please choose “high” in the “resolution” option。

When the case meets much disturbance, please choose “high” in the “precision of judging interfering”

option。Analysis precision and precision of judging interfering don’t need to adjust generally. The user

can choose according to the actual circumstances.

Click and enter the picture as fig.6-6.

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fig. 6-6

Click , the system will stop temporarily. User can browse the 3 lead ECG through “←↑→↓”

on the keyboard. In the heart rate trend graph, there is a green symbol line, which represents the place of

the current wave. User can go back to a point ,change condition(analytical

leads,discernment,discernment in disturb),click , the part behind the green sign will be

analysed again. (as fig.6-7).

3 minutes RR interval trend graph

HR trend graph

3-lead wave in-phase

Choose analyzing leads

33


fig. 6-7

Click in the analytical process, the analysis will stop temporarily. Or use “space” to switch

"start/stop”.

When the analysis finished, press “←↑→↓”on the keyboard to go back to certain point to analyse again

if necessary.

When the analysis finished, user can enter different module by choosing different options.

Function explanation of edit module

Represent: Arrhythmia analysis module, template replay ， order

replay module，HRV analysis module, HRT module, TWA module.

Go to the previous operation go to the next operation

◇ scroll bar usage

Click the “▲▼” at the right side of the Window or scroll bar to change the content shown in the

window.

◇ Change window size

Move the mouse arrowhead to the side of box,when the arrowhead turn to “↔”or“↕”,press the left

keypad of mouse and don't set free until drag to the wanted location.

◇ Screen interface distributing

Click into the replay module。(as fig.6-8)

34


fig. 6-8

The left window is the template window. Every button is a template. The letter in the button represents

the type (for example: v means ventricular premature beat, s means atrial premature beat) ， the

percentage means what percentage this kind is in the total. The blank means no wave.

V: ventricular premature beat module AF: atrial flutter module

S: atrial premature beat module Af: atrial fibrillation module

N: NN heart pacing module VF: ventricular flutter module

L: long interval module Vf: ventricular fibrillation module

Double click here to magnify the wave

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O: interfering module

If it is pacing case, then the template will increase 11 classes automatically, shown as fig.6-9 .

fig. 6-9

They are:

D：Dual chamber pacing AP：Atrial Pacing

AUS：Atrial Under Sense AOS：Atrial Over Sense

AOO：Atrial asynchronous pacing

VP：Ventricular pacing VUS：Ventricular Under Sense36


VOS：Ventricular Under Sense VFB：Ventricular fusion beat

VO：Ventricular Pseudofusion VOO：Ventricular asynchronous pacing

If it is pacing case, under the ECG shown ,there will be marker with blue lines, the position on the ECG

is pacing point.

The right window above is a display of the chosen module to display concrete wave.

The right window below is the detail what the arrowhead points to at the right window above.

Press to enter the following interface to adjust classifying parameters.As fig.6-10.

Backwards age

Which Page

Forwards page

Page number

37


fig. 6-10

The left is the parameter name and unit. The middle is about how many kinds the parameter divided

into. The right is the verge of the classification. The verge of the classification is in accordance with

the lines in the distributing graph.

fig. 6-11

Picture 6-11 shows the distributing graph of the wave. The y-axis is the number of wave ,the

abscissa is attribute value of wave. The classified line corresponds to the editor box。Press the

square in the line to move the line to change the verge of the classification. The blue triangle on the

left is the amplified staff guage。

This box decides whether to sort the waves according to shape.

Wave display window.As fig.6-12

fig. 6-12

When the number of classification is large, it’s used to turn the pages. The number in the middle means the current page.

The number in the square means the number of the waves. The two rectangles on the right mean there are two parameters to be classified, including height and interval. The number of diamonds in quadrate bar is the classified number according to the parameters.The purple square means the place of the wave. For example, the first kind in the above, the height of the R wave is between 0.64 and 1.22, and the RR interval is between 520 and 948. Keep the left button down, drag the wave into the classify moulding board. It can change the class of these waves.

38


When knocking the correspond button, the system calculates the proper circumscription of the

classification, and divides the parameter into some kinds automatically. For example, when knocking the

"Disturb classification" button, the system calculates the proper circumscription of the classification, and

divides the parameter into three kinds automatically. When knocking the "Shape classification " button,

the system will divide into four kinds automatically. When knocking the "High classification " button,

the system will divide into three kinds automatically.

is "choose insert wave" button. When knocking this button, the system will choose the inserting

wave out to make the user easy to edit.

Open dialog box to add classify.

Click the right button open the editor menu.

Change the class

module; at the same time

put the waveform, which is

changed into the module.

Shape classification Interval classification Width classification Choose insert wave

Add new templet

Disturb classification Interval classification High classification Area classification

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Shortcut key

“V”, “S”, “N”, “L” are the shortcut key to change the chosen wave to the corresponding sort.

“Page up”, “page down”, “home”, “end”, “↑”, “↓”mean page up, page down，to the beginning of

the page, to the end of the page, up and down。

Control graph display key

Remove the ECG in the left window up

Remove the ECG in the left window down

Remove the ECG in the left window left

Remove the ECG in the left window right

Amplify the ECG in the left window

Lessen the ECG in the left window

Cancel the edit operation

Recover the edit operation

Display or hide the statistics

Display or hide the time

Choose all the ECG in the left window

Reverse choice the wave in the left window

Cancel choice in the left window

click the button and enter order replay module.

The picture is the order replay picture of main analysis lead. And the doctor can choose the wave of

other leads.As fig.6-13

40


fig. 6-13

Put the arrowhead on the ECG and knock the right key of the mouse, then appear the menu as fig.6-14.

The physician can examine and analyze the ECG according to what he needs.

Waveform area

Trend graphic area

Trend graphic areaEvent Marker

41


fig. 6-14

For example, knock “the highest heart rate”, and appear the highest heart rate ECG, which is for the

main analytical lead. Of course, the physician can choose other lead according to what he needs. As

fig.6-15

fig. 6-15

42


In this picture, knock the right key of the mouse, appear , and choose “Confirm

MaxHR”, then show the highest heart rate. As fig.6-16.

fig. 6-16

Knock button, show the multi-lead ECG.As fig.6-17.

43


fig. 6-17

Knock button, show supra ventricular electrocardiogram

44


fig. 6-18

Knock button, show ventricular electrocardiogram。As fig.6-19

45


fig. 6-19

Change type into ventricular premature beat change type to atrial premature beat

Change type to sinus pulsation change type to long intermission

Change type to atrial flutter change type to atrial fibrillation

Change type to ventricular flutter change type to ventricular fibrillation

Change type to disturb delete

Press CTRL, and choose the bar picture by mouse at the same time, are just used for

deleting, not others.

Knocking the button, enter ST elevation ECG.

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fig. 6-20

Knocking button, display ST depression electrocardiogram。

The physician can “choose lead” according to what he

needs to input the parameter. The parameter should be

between 0.01 and 0.3. If the input number is out of the

range, the computer will display

。Click

47


fig. 6-21

Click button, display other classified ECG: couple S, S bigeminal rhythm, S trigeminal rhythm,

atrial tachycardia; ventricular tachycardia, couple V, V bigeminal rhythm, V trigeminal rhythm; long

intermission, atrial flutter, atrial fibrillation, ventricular flutter, ventricular fibrillation; maximal heart

The physician can “choose lead” according to what he

needs to input the parameter. The parameter should be

between 0.01 and 0.3. If the input number is out of the

range, the computer will display:

48


rate, minimal heart rate.

Before do the operations, which have been introduced, if refresh button (high bright) means the

data need refresh, click this button to refresh data.

Click button to display single lead ECG waveform.

Click button, display the Arrhythmia Table .

Arrhythmia Table A as fig.6-22.

fig. 6-22

Arrhythmia Table B as fig.6-23.

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fig. 6-23

Click button，enter HRT analysis module.

HRT could be quantificationally expressed by two parameters,the two parameters are TO and TS.

Ventricular premature beat causes artery blood pressure brief foul-up.When the adjustable function is

natural,this transitory change will be represented by the form of HRT immediately; when the adjustable

function is injured,the change will weaken or disappear as fig.6-24：

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fig. 6-24

The position marked “HRT beginning” is the beginning position of wave that satisfies HRT judged

condition,the third QRS wave after this position is ventricular premature beat ，you can see the RR

interphase trend graph in the whole HRT occurring term in the left below graph ,which have signed the

TO,TS segment with red line to make the user more convenient to judge.

Click the button in toolbar will display the wave that satisfies last

HRT analysis condition,Click the button will display the wave that satisfies next HRT analysis

51


condition,click will display the HRT waveform after superposition on the left below window

graph as fig. 6-25:

fig. 6-25

The erect line on the dot express RR interphase the maximal value and least value on different period of

time.

The three row number below graph express the RR interphase the maximal value ,the average and least

value for the corresponding dot.

The graph on the right below window is the conclusion as fig.6-26：

fig. 6-26

Before seeing the whole case report,the option such as "normal heart pacing" will show the word "no

judging".When the result is in the range that "the dangerous exponent" indicates ,the corresponding

result will turn to red to remind the user.

Click button to enter the T Wave alternation analysis module .

TWA express the alternate change of amplitude ,form about T wave on the ECG.TWA have

consanguineous relation with Arrhythmia.The amplitude,form and periodicity of T wave of the same

lead change alternately on the ECG,the wave that amplitude difference of near waves is same or larger

52


than 1 mm is called TWA. TWA is a important index on judging and preventing Arrhythmia .

The analysis adopts TWA measure basing on the maximum of T wave.The general method is：choose

continuous 8（16、32、……128）waveform，number QRS waveform from the first one,such as

1、2、3、……、8,then compare the maximum of T wave;if the difference of T wave is larger than the

range that has preestablished,there is TWA phenomena.After comparing, carry out superposition of the

singular number (1 、 3 、 5……)wave and superposition of dual number(2 、 4 、 6……)wave

respectively,then draw the result after superposition,it will be more obvious as fig.6-27:

fig. 6-27

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The position marked “TWA beginning”, “TWA end” is the section of wave that satisfies TWA judged

condition.On the left ,it is the superposition graph of the singular number wave and dual number

wave.The green line is the superposition wave of the singular number , the red line is the superposition

wave of the dual number. If there are red words below wave ,it means there is TWA phenomenon for

this lead (such asV3-lead,V4-lead on above picture ).The number express the height difference after

superposition of the singular number wave and superposition of dual number wave.Click the rectangle

where the wave is , the right wave graph will turn to single-lead wave of the appointed lead."heart rate

trend graph ","RR interphase trend graph " above express the heart rate of TWA segment and the

mutative trend of RR interphase .

Click button in toolbar will display the wave that satisfies last TWA

analysis condition,Click the button will display the wave that satisfies next TWA analysis

condition.

and express the switch between single lead and multi-lead for the current displaying waves.

is the enactment button,click it,then the following dialog box will appear:

The user can set the TWA judging standard and the heart pacing longness for continuous measuring. The

range for TWA judging standard is40－100mV,the heart pacing longness for continuous measuring is：

8－128。The purpose of enactment is analysis convenience and reducing mistake.

Click button to measure RR and PR interval.

54


Click button to modify the type of QRS wave.

Under such situation, the waveform could be modified continuously. Move the mouse to the beginning

of the waveform which needs modification, click the right button to choose the start position, then move

to the end, click the right button again to make sure the end position. Now the segment can be modified.

Put the red target on the ECG,

pressing the left button and dragging

the red target, when there appears a

blue rectangle, release the mouse,

then the result of measure will turn

on.

Put the mouse pointer which has the blue rectangle on the wave of QRS that need to modify, then you can click the left button to modify the wave.

For example: put the blue rectangle on the S that need to modify in the left picture, click the left button and the S will change to V, then continue click the V, you will get the O.

55


Choose the start pos choose the end pos modify the waveform in series

In the order replay interface, select the “Atrial Fibrillation” in the “Arrhythmia” menu to analyse the

atrial fibrillation of the case that the arrhythmia has been construed. The atrial fibrillation analysis

system will enter the interface as fig.6-28 automatically.

56


fig. 6-28

It is similar to the interface of order replay, but add the azury diagram at the top of HR trend. It is the

RR interval of the current position that displayed. At the same time, there is a red rectangle appear on

the multi channel graph. The waveform that the red rectangle indicates is the same as the waveform on

the RR interval graph.

The user can choose any parts of RR interval to scan by using the HR trend at the bottom. User also can

click directly. Use the to roll forwards or backwards and use the to turn over the page.During

this process, the multi-channel graph and the green line on the HR trend will change at the same time.

You will see that there are azury, navy blue, gray and some white lines on the RR interval graph. Their

meaning is as follows:

The azury is general waveform; The navy blue means the continuous S, V, AF, Af, VF, Vf( the concrete

meaning see the template elucidation part) etc.; Gray means the continuous artefacts;The white lines 57


means interference segment.

System support keyboard to view RR interval trend graph. Click the view below, passing the " → "" ← "

can view the RR interval forward or backward, passing the " Page Up"," Page Down", can turn over the

page backward or forward, you can also pass the " ↑ " " ↓ "to play the RR interval automatically , and

press any key to stop playing.

The user can judge the atrial fibrillation occurrence time and length assumably by using RR interval

graph. Combining the multi channel graph, if make sure that the segment is AF; pop up the menu as

follows on the RR interval by clicking the right button:Choose a segment, when the segment turn red, its

attribute can be modified to S Tachycardia, V Tachycardia, Atrial flutter, Atrial fibrillation, Ventricle

flutter, Ventricle fibrillation, Normal, disturb. At the same time, user also can choose automatic atrial

fibrillation analysis for this segment. You also can choose the whole automatic atrial fibrillation analysis

at the beginning.

58


fig. 6-29

Click button to print multi-channel ECG.

Click button to cancel the print.

Click button to fresh data。

Click button, enter the arrhythmia analysis module.

Note: Click button, the system enters sinus mode arrhythmia analysis.Which is the default

analysis.

Click button，the system analyse all pulsation arrhythmia.

Click button，display 5minutes arrhythmia analysis graph。

The frequency domain, time domain and the integration electrocardiogram in 5 minutes. You can print

them, can change the starting time by moving the y-axis line in the below trend graph,can change page

by moving the scroll bar in the top right window.As fig.6-30.

Click button to display the all pulsation arrhythmia graph in 5 minutes.(as fig.6-31)

59


60


fig. 6-30 fig. 6-31

Click button to display arrhythmia analysis graph in an hour.

The frequency domain, time domain and the integration electrocardiogram in one hour. You can print

them, can change the starting time by moving the y-axis line in the below trend graph,can change page

by moving the scroll bar in the top right window.As fig.6-32.

Click button to display the whole pulsation arrhythmia graph in an hour.As fig.6-33.

61


62


fig. 6-32 fig. 6-33

Click button to display the whole process RR interval histogram. As fig.6-34

Click button to display the whole pulsation RR interval histogram. As fig.6-35

63


64


fig. 6-34 fig. 6-35

Click button to display the whole process RR interval dispersion histogram. (as fig.6-36)

Click button to display the whole pulsation RR interval dispersion histogram. (as fig.6-37)

65


66


fig. 6-36 fig. 6-37

Click button to display the whole pulsation RR interval poincare. (as fig.6-38)

Click button to display all pulsation RR interval poincare. (as fig.6-39)

67


68


fig. 6-38 fig. 6-39

Click button to display sinus mode pulsation RR interval dispersion poincare. (fig.6-40)

Click button to display the whole pulsation RR interval dispersion poincare. (fig.6-41)

69


70


fig. 6-40 fig. 6-41

Click button to display sinus mode pulsation spectrum graph (fig.6-42).

Click button to display the whole pulsation spectrum graph (fig.6-43).

71


72


fig. 6-42 fig. 6-43

Click button to display 3D sinus mode pulsation spectrum graph(fig.6-44).

Click button to display the whole pulsation spectrum graph(fig.6-45).

73


74


fig. 6-44 fig. 6-45

Click button to display all process analysis compositive graph (fig.6-46)

Click button to display the whole pulsation analysis compositive graph（fig.6-47）

75


76


fig. 6-46 fig. 6-47

Click button to display all process heart rate aberrance trend graph (fig.6-48).

Click button to display heart rate aberrance trend graph of the whole pulsation(fig.6-49).

77


78


fig. 6-48 fig. 6-49

Click button， through to display the whole heart rate variability data table (fig.6-50)

Click button, through to display the heart rate variability data table of of the whole pulsation (fig.6-51)

79


80


fig. 6-50 fig. 6-51

Click button to display the case report ,sleeping time and additional analysis. (fig.6-52)

81


The number of ST elevation or depression and the number of T wave invertion.

82


83


fig. 6-52

Attention: If it is pacing case, the main analysis result is in the additional analysis.

Attention: If the report stat. data is not match before, the reason may be that your report have not

updated the latest modification result, you need click" calculation", then click" OK"

Attention :The data about sleeping time must be filled in according to fact.

Click button to display the print graph. The physician could choose what kind graph to print.

(fig.6-53)

84


fig. 6-53

Click button to remove the single time in the left frame into the right and wait to print.

Click button to remove all the time in the left frame into the right and wait to print.

Click button to remove the single time in the right frame into the left and cancel the print.

Click button to remove all the time in the right frame into the left and cancel the print.

Click button and enter the parameter definition operation.As fig.6-54.

85


fig. 6-54

If the physician wants to analyse the case again, he can open the following dialog box as fig.6-55.

fig. 6-55

Open the “Maintain” item in the “File”, the physician can operate the case by “delete”, “open”,

“modify” and so on. Double click the item to open the case。Select the item which to be deleted，click

to delete the case. Click the head of table，then the information of this list will be arranged again.

Click to display the informations in turn. Select item and click to modify the information.

The item which has an icon indicates that this item has case, contrarily, has no case.

86


fig. 6-56

Pacing analysis

When the data contain pacing signal, the system can identify it automatically and add the pacing analytical function.As fig.6-57.

87


fig. 6-57

There are 11 button.Every button represents a module. The letter in the button means the name of the

kind. (For example, D means dual chamber pacing). The percentage in the button means what

percentage the wave is in the amount.

D: dual chamber pacing AP: atrial pacing

AUS：atrial less sense AOS： atrial over sense

AOO：atrial no pacing VP： ventricle pacing

88


VUS：ventricle less sense VOS： ventricle over sense

VFB：ventricular fusion beat VO： ventricle pseudofusion

VOO：ventricle no pacing

Enter

the

order

replay,

click

the

button

and

appear

the

“Data

Table”

dialog

box

which

added

the

“Pacin

g

Analys

is Data

Table”

as

fig.6-

58. All

kinds

of data

Start.

can be

gotten

from it.

89


fig. 6-58

Sleep breath pause syndrome analysis

First,make sure that the time when the patient begins to use recorder is correct,as fig.6-59.

90


fig. 6-59

In case report please fill the correct sleep time and wake time about sleeping time segment as

fig.6-60：

91


fig. 6-60

Last,in printing function dialog box ， please choose "trend graph","multi-parameter

contrast","danger analysis" about the option of sleep asphyxia analysis graph, as fig.6-61.

92


fig. 6-61

After confirming, the physician could print sleep asphyxia analysis report and diagnose.

Appendix Technical SpecificationⅠ

1、Scale voltage：1mV±5%

2、Standard Sensitivity:10mm/mV±5%

3、Noise level:≤30μV

4、CMRR:≥60dB

5、Frequency response: 10Hz as benchmark ,0.5Hz～55Hz；-3dB

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6、Time constant:Time constant>3.2s

7、Scan speed:25mm/s±5%

8、Enduring polarization voltage:±300mV

9、Least measure signal:50 µV p-p

10、Interfere between channels:scan track deflexion (result from interfere between channels)<0.5mm

11、Product safety type:Type B (Internally powered)

12、Size:111mm（L）*60mm(W)*25mm（H）

13、Net Weight: 105g (Without battery)

94

tlc9803_EN2008.08.27

Documents

manual strictlythe environment

dont use device

recorder analysis software

contents1 chapter

lead ecg waveform

defibrilation device

recorder operation explanation

malfunction analysis